ROSUVASTATIN MC 5 rosuvastatin 5 mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
11-04-2022

有効成分:

rosuvastatin calcium, Quantity: 5.21 mg (Equivalent: rosuvastatin, Qty 5 mg)

から入手可能:

Medreich Australia Pty Ltd

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: crospovidone; meglumine; lactose monohydrate; pregelatinised starch; purified water; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide yellow

投与経路:

Oral

パッケージ内のユニット:

15, 30, 45, 60 (dispensing pack) and 90 (dispensing pack) tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

ROSUVASTATIN MC should be used as an adjunct to diet when the response to diet and exercise is inadequate.,Prevention of cardiovascular events,ROSUVASTATIN MC is indicated for prevention of major cardiovascular events in men ?50 years old and women ?60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). ROSUVASTATIN MC is indicated to:,? Reduce the risk of nonfatal myocardial infarction,? Reduce the risk of nonfatal stroke,? Reduce the risk of coronary artery revascularisation procedures.,In patients with hypercholesterolaemia,ROSUVASTATIN MC is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).,Prior to initiating therapy with ROSUVASTATIN MC, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

製品概要:

Visual Identification: Yellow, round, film-coated tablets debossed with 5 on one side and R on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2022-03-03